Update of IEC 60601-1 certification for medical devices

The IEC 60601-1 certification is an international standard that certifies the compliance of a medical device with safety and performance standards. This standard contains a series of general requirements and establishes the fundamental characteristics for the safety and essential performance of electromedical equipment.

The IEC 60601-1 standard therefore becomes crucial, as well as mandatory, to guarantee the compliance and safety of medical devices at an international level. To obtain this certification, manufacturers must demonstrate that their medical device positively meets all the safety and performance requirements established by the IEC 60601-1 standard.

The certification process has several phases and includes laboratory tests, evaluations of technical documentation and checks of physical production facilities. The IEC 60601-1 standard is not static and is constantly updated; since its first publication in 1977 it has undergone various developments. With the transition from the 2nd to the 3rd edition, the standard saw the most important change: let's clarify the update in progress.

What does revision 3.2 of the IEC 60601-1 standard consist of?

Version 3.2 of the IEC-60601-1 standard establishes rigorous requirements to ensure patient safety when using electromedical medical devices and includes updates that reflect the latest knowledge and best practices in the sector, thus contributing to minimizing risks to patient health.

The 3.2 edition of the IEC 60601-1 standard represents the most widespread standard in the medical field. It is used in the United States, Canada, the European Union, Japan, Brazil, Russia and Australia.

Version 3.2 was officially recognized by the FDA and went live at the end of 2023; below we have included a non-exhaustive list of the main innovations introduced.

Update of regulatory references: with the new version some references to the main standards have been replaced, for example from the IEC 60950-1 standard to the IEC 62368-1 standard, more up-to-date in the identification of electronic devices.

Update of definitions and terminologies: some terms have been expanded and redefined, such as the concepts of damage, risk, severity and processes.

Update on warning signs and indicators: safety symbols and markings must now also be used to indicate which accompanying documents should be consulted for further safety information.

Hazard Protection Update: New instructions for measuring voltage and leakage current values with more precise classification of means of protection.

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The Digimax proposal with updated IEC 60601-1 certification

Certified power supplies for medical devices

Certified open-frame power supplies for medical devices are the most used in this sector and with the new MAD50 series, from 15 W to 450 W, all the protections required by the regulations are guaranteed: short circuit, overload and overvoltage. The series is very compact (3"x1.5") and provides a continuous output power of 50W, with a peak power function that allows the power supply to provide up to 140% of rated output power for 5 seconds.

This series is designed with a conversion efficiency of up to 92.5%, allowing full power operation from -40℃ to +55℃ ambient temperature without derating or forced air cooling. The universal input voltage range is 85-264 VAC (120-370 VDC), and outputs are available from 5 VDC to 53 VDC, with output regulation from -10% to +10% or -20% to +10%, depending on the output voltage.

The MAD50 series also integrates a EMC filter compliant with EN 55032 prioritizes patient safety through the use of high-quality components and excellent thermal management, perfect features for a variety of medical applications, such as pulse oximeters, devices portable ultrasound systems, mobile C-arm systems, ambulatory infusion pumps, portable ECG monitors and more.

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